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Voltaren Anti-inflammatory and anti-rheumatic product, non-steroid, acetic acid
derivative and related substance.
COMPOSITION AND PHARMACEUTICAL FORM
The active substance is sodium-(o-[(2,6-dichlorophenyl)amino]-phenyl acetate
(=diclofenac sodium).
One Voltaren ampoule of 3 mL contains 75 mg of diclofenac sodium.
For excipients, see section EXCIPIENTS.
Solution for injection.
DESCRIPTION
Clear, colourless to faintly yellow liquid.
INDICATIONS
Intramuscular injection
Treatment of:
• Exacerbations of inflammatory and degenerative forms of rheumatism:
rheumatoid arthritis, ankylosing spondylitis, osteoarthritis,
spondylarthritis, painful syndromes of the vertebral column, non-articular
rheumatism.
• Acute attacks of gout.
• Renal colic and biliary colic.
• Post-traumatic and post-operative pain, inflammation and swelling.
Intravenous infusion
Treatment or prevention of post-operative pain in a hospital setting.
DOSAGE AND ADMINISTRATION
As a general recommendation, the dose should be individually adjusted and
the lowest effective dose given for the shortest possible duration.
Adults
Voltaren solution for injection should not be given for more than 2 days; if
necessary, treatment can be continued with Voltaren tablets or
suppositories.
Intramuscular injection
The following directions for intramuscular injection must be followed in
order to avoid damage to a nerve or other tissue at the injection site.
The dose is generally one 75 mg ampoule daily, given by deep intragluteal
injection into file upper outer quadrant. In severe cases (e.g. colic), the
daily dose ran exceptionally be
increased to two injections of 75 mg, separated by an interval of a few
hours (one into each buttock). Alternatively, one ampoule of 75 mg can be
combined with other pharmaceutical forms of Voltaren (e.g. tablets,
suppositories) UP to a total maximum daily dose of 150 mg.
Intravenous infusion
Voltaren solution for injection must not be given as an intravenous bolus
injection.
Immediately before starting an intravenous infusion, Voltaren solution for
injection must be diluted with saline 0.9% or glucose 5% infusion solution
buffered with sodium bicarbonate according to the instructions given in
section
INSTRUCTIONS FOR USE AND HANDLING.
Two alternative dosage regimens
of Voltaren solution for injection are recommended.
For the treatment of moderate to severe post-operative pain, 75 mg should be
infused continuously over a period of 30 minutes to 2 hours. If necessary,
treatment may be repeated after a few hours, but the dose should not exceed
150 mg within any period of 24 hours.
For the prevention of post-operative pain, a loading dose of 25 mg to 50 mg
should be infused after surgery over 15 minutes to 1 hour, followed by a
continuous infusion of about 5 mg per hour up to a maximum daily dose of 150
mg.
Children and adolescents
Because of their dosage strength, the ampoules of Voltaren solution for
injection are not suitable for children and adolescents.
CONTRAINDICATIONS
• Known hypersensitivity to the active substance, sodium
rnetabisulphite or any of the other excipients.
• Active gastric or intestinal ulcer, bleeding or perforation.
• Last trimester of pregnancy (see section PREGNANCY AND
LACTATION).
• Severe hepatic renal and cardiac failure (see section
SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
• Like other non-steroidal and-inflammatory drugs (NSAIDs),
Voltaren is also contraindicated in patients in whom
attacks of asthma, urticaria, or acute rhinitis are
precipitated by acetylsalicylic acid or other NSAIDs.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Warnings
Gastrointestinal bleeding ulceration or perforation, which can be fatal,
have been reported with all NSAIDs and may occur at any time during
treatment, with or without warning symptoms or a previous history of serious
gastrointestinal events. They generally have more serious consequences in
the elderly. it gastrointestinal bleeding or ulceration occur in patients
receiving Voltaren, the medicinal product should be withdrawn.
Serious skin reactions, some of them fatal, including exfoliative
dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have
been reported very rarely in association with the use of NSAIDS, including
Voltaren (see section UNDESIRABLE EFFECTS). Patients appear to be at highest
risk of these reactions early in the course of therapy, the onset of the
reaction occurring in the majority of cases within the first month of
treatment. Voltaren should be discontinued at the first appearance of skin
rash, mucosal lesions or any other sign of hypersensitivity. As with other
NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions,
can also occur in rare cases without earlier exposure to diclofenac. The
sodium rnetabisulphite in the solution for injection can also lead to
isolated severe hypersensitivity reactions and bronchospasm. Like other
NSAIDs, Voltaren may mask the signs and symptoms of infection due to its
pharmacodynamic properties.
Precautions
General
The concomitant use of Voltaren with systemic NSAIDs including
cyclooxygenase-2 selective inhibitors, should be avoided due to the absence
of any evidence demonstrating synergistic benefits and the potential for
additive undesirable effects.
Caution is indicated in the elderly on basic medical grounds. In particular
it is recommended that the lowest effective dose be used in frail elderly
patients or those with a low body weight.
Pre-existing asthma
In patients with asthma, seasonal allergic rhinitis, swelling of the nasal
mucosa (i.e. nasal polyps), chronic obstructive pulmonary diseases or
chronic infections of the respiratory tract (especially if linked to
allergic rhinitis-like symptoms), reactions on NSAIDs like asthma
exacerbations (so-called intolerance to analgesics / analgesics-asthma),
Quincke's oedema or urticaria are more frequent than in other patients.
Therefore special precaution is recommended in such patients (readiness for
emergency). This is applicable as well for patients who are allergic to
other substances, e.g. with skin reactions, pruritus or urticaria. Special
caution is recommended when Voltaren is used parenterally in patients with
bronchial asthma because symptoms may be exacerbated.
Gastrointestinal effects
As with all NSAIDs, close medical surveillance is imperative and particular
caution should be exercised when prescribing Voltaren in patients with
symptoms indicative of gastrointestinal (GI) disorders or with a history
suggestive of gastric or intestinal ulceration, bleeding or perforation,
(see section UNDESIRABLE EFFECTS). The risk of GI bleeding is
higher with increasing NSAID doses and in patients with a history of ulcer,
particularly if complicated with haemorrhage or perforation and in the
elderly. To reduce the risk of GI toxicity in patients with a history of ulcer,
particularly if complicated with haemorrhage or perforation, and in the
elderly, the treatment should be initiated and maintained at the lowest
effective dose.
Combination therapy with protective agents (e.g. proton pump
inhibitors or misoprostol) should be considered for these patients, and also
for patients requiring concomitant use of medicinal products containing
low-dose acetylsalicylic acid (ASA)/aspirin, or other medicinal products
likely to increase gastrointestinal risk.
Patients with a history of GI toxicity, particularly the elderly, should
report any unusual abdominal symptoms (especially GI bleeding). Caution is
recommended in patients receiving concomitant medications which could
increase the risk of ulceration or bleeding, such as systemic
corticosteroids, anticoagulants, anti-platelet agents or selective
serotonin-reuptake inhibitors (see section INTERACTIONS).
Close medical
surveillance and caution should also be exercised in patients with
ulcerative colitis or Crohn's disease, as their condition may by exacerbated
(see section UNDESIRABLE EFFECTS).
Hepatic effects
Close medical surveillance is required when prescribing Voltaren to patients
with impaired hepatic function, as their condition may be exacerbated.
As with other NSAIDs, values of one or more liver enzymes may increase.
During prolonged treatment with Voltaren (e.g. in the form of tablets or
suppositories), regular monitoring of hepatic function is indicated as a
precautionary measure. If abnormal liver function tests persist or worsen,
if clinical signs or symptoms consistent with liver disease develop, or if
other manifestations occur (e.g. eosinophilia, rash), Voltaren should be
discontinued. Hepatitis may occur without prodromal symptoms.
Caution is called for when using Voltaren in patients with hepatic porphyria,
since it may trigger an attack.
Renal effects
As fluid retention and oedema have been reported in association with NSAID
therapy, particular caution is called for in patients with impaired cardiac
or renal function, history of hypertension, the elderly, patients receiving
concomitant treatment with diuretics or medicinal products that can
significantly impact renal function, and in those patents with substantial
extracellular volume depletion of any cause, e.g. before or after major
surgery (see section
CONTRAINDICATIONS). Monitoring of renal function is recommended as a
precautionary measure when using Voltaren in such cases. Discontinuation of
therapy is normally followed by recovery to the pre-treatment state.
Haematological effects
During prolonged treatment with Voltaren, as with other NSAIDs, monitoring
of the blood count is recommended. Like other NSAIDs, Voltaren may
temporarily inhibit platelet aggregation. Patients with defects of
haemostasis should be carefully monitored.
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